StrokeNCT06746493
The Assessment of Knee Joints Function in People After Stroke
An observational study of Stroke, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
The study aims to assess the function of knee joints in patients after stroke compared to healthy people and evaluate the impact of rehabilitation on the function of knee joints in people after stroke. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Rehabilitation
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 10 Nov 2021to 15 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study group comprised patients after stroke. The control group consisted of healthy volunteers.
Who may be able to join
- the time from stroke: less than a year,
- age: between 35 and 65 years old,
- ability to stand independently for at least 5 minutes without an assistive device,
- ability to walk 5 m independently,
- ability to communicate and understand the tasks required in the study,
- a modified Ashworth scale spasticity score of 1+ or less in the affected knee (0: no resistance, 5: affected parts stiff in flexion or extension),
Show all 22Show fewer
- muscle strength on the Manual Muscle Test of 3/4 or more in the affected knee,
- Barthel Index score 80 or more.
- Exclusion criteria from the post-stroke group were as follows:
- age below 35 or over 65,
- sensorimotor aphasia,
- cognitive disorders that make it impossible to understand and obey commands,
- lack of active movement in the knee joint,
- Manual Muscle Test strength of the quadriceps muscles below 3,
- no ability to walk 5 meters,
- lack of informed consent to participate in the study,
- other neurological diseases (such as MS, Parkinson's disease, neuropathies),
- fractures in the lower limbs, which could affect the structure and function of the knee joint,
- previous operations on the lower limbs (including ACL reconstruction, knee arthroplasty or hip, osteotomy of the knee joint).
- vision disorders,
- unilateral spatial neglect syndrome.
- The control group consisted of healthy volunteers with no prior history of trauma or neurological disease affecting the structure and function of the lower limb.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is it Important to Assess the Function of the Knee Joint After a Stroke
The study aims to assess the function of knee joints in patients after stroke compared to healthy people and evaluate the impact of rehabilitation on the function of knee joints in people after stroke.
Read the detailed description
Stroke patients were examined twice at the beginning of rehabilitation and after approximately 15 days of exercise. The control group (healthy participants) was assessed once. Wireless motion sensors connected to a mobile application were used to assess the kinematics of the knee joints. They were used to assess the range of motion in the knee joints (passive, active, active at maximum speed), proprioception (joint position sense tests), step-up test, step-down test, getting up and sitting on a chair, step and squat. Functional tests such as The Five Times Sit-to-Stand Test, Timed Up\&Go, The Step Test, the 5m walking test, and the 30-s Chair Stand Test were carried out. The strength of the knee extensors and flexors was also assessed using the Leg Force Feedback device. Balance was assessed on a posturography platform by performing tests such as standing with eyes open and closed on a stable surface and standing with eyes open and closed on an unstable surface. The symmetry of lower limb loads in a standing position was also assessed.
- Conditions
- Stroke
- Being tested
- Rehabilitation
- Keywords
- function of knee joint, physiotherapy, wireless sensors, functional tests
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Also called Physical rehabilitation
People after a stroke participated in a standard rehabilitation process carried out at the neurological rehabilitation department.
| Study group | Role | What they receive |
|---|---|---|
| Stroke group | All patients from the stroke group were examined twice at the beginning and the end of this trial by a physical therapist. Patients participated in a rehabilitation program at the Neurological Rehabilitation Department between measurements. Receives: Other: Rehabilitation | |
| Control group | The control group consisted of healthy subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the passive and active range of motion of the knee joint using wireless motion sensors connected to a mobile application.
Measurement of the passive and active range of motion of the knee joint in degrees in lying position using wireless motion sensors connected to a mobile application.
Measured: Baseline and after about 15 days of exercise.
Proprioception
Assessment of joint position sensation (3 different positions indicated) in degrees using wireless sensors.
Measured: Baseline and after about 15 days of exercise.
Assessment of the active range of motion of the knee and hip joint during functional tasks
Measurement of the range of motion of the knee and hip joint using wireless motion sensors connected to a mobile application during functional tasks such as: step up, step down, squat, sitting on a chair and getting up from a chair and step forward.
Measured: Baseline and after about 15 days of exercise.
Assessment of the maximum angle of varus and valgus at the knee joint during functional tasks
Measurement of the maximum angle of varus and valgus at the knee joint using wireless motion sensors connected to a mobile application during functional tasks such as: step up, step down, squat, sitting on a chair and getting up from a chair and step forward.
Measured: Baseline and after about 15 days of exercise.
Assessment of the mean squared error at the knee joint during functional tasks
Measurement of the mean squared error using wireless motion sensors connected to a mobile application during active flexion and extension motion in the knee joint at maximum speed and functional tasks such as: step up, step down, squat, sitting on a chair and getting up from a chair and step forward.
Measured: Baseline and after about 15 days of exercise.
Assessment of the speed of movement in the knee joint during functional tasks
Measurement of the speed of movement in the knee joint during active flexion and extension motion in the knee joint at maximum speed and functional tasks such as: squat and sitting on a chair and getting up from a chair.
Measured: Baseline and after about 15 days of exercise.
Step test
Assessment of the number of repetitions.
Measured: Baseline and after about 15 days of exercise.
The Five Times Sit-to-Stand Test
Assessment of task completion time.
Measured: Baseline and after about 15 days of exercise.
Timed Up&Go Test
Assessment of task completion time.
Measured: Baseline and after about 15 days of exercise.
30-s Chair Stand Test
Assessment of the number of repetitions.
Measured: Baseline and after about 15 days of exercise.
5m walking test
Assessment of task completion time.
Measured: Baseline and after about 15 days of exercise.
Assessment of isometric muscle strength of knee flexors and extensors using Leg Force Feedback device.
Measurement of the maximal voluntary isometric contraction torque of the knee extensor and flexor muscle groups in Newton-meter.
Measured: Baseline and after about 15 days of exercise.
Symmetry
Assessment of the load on the lower limbs while standing in percentage.
Measured: Baseline and after about 15 days of exercise.
Secondary outcomes (3)
Assessment of the center of pressure path length when measuring on a balance platform
Measurement of parameter such as total path length (cm). A test was performed in four conditions: standing with eyes open and closed on a stable surface and standing with eyes open and closed on an unstable surface.
Measured: Baseline and after about 15 days of exercise.
Assessment of the center of pressure velocity when measuring on a balance platform
Assessment of parameter such as average speed (cm/s). A test was performed in four conditions: standing with eyes open and closed on a stable surface and standing with eyes open and closed on an unstable surface.
Measured: Baseline and after about 15 days of exercise.
Balance
The test was performed in four conditions: standing with eyes open and closed on a stable surface and standing with eyes open and closed on an unstable surface. The results were obtained in percentage values and compared to the normative results from the system.
Measured: Baseline and after about 15 days of exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start10 Nov 2021
- Primary completion7 Apr 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Wareńczak-Pawlicka, Poznan University of Medical Sciences
- Investigators
- Agnieszka Wareńczak-Pawlicka, PhD, Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746493
- Sponsor's protocol ID
- 822/21
- Status last verified
- Dec 2024
- First submitted
- 11 Mar 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is available in the form of an anonymized CSV sheet.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Important to Assess the Function of the Knee Joint After a Stroke
- ClinicalTrials.gov ID
- NCT06746493
- Acronym / sponsor ID
- 822/21
- Conditions
- Stroke
- Keywords
- function of knee joint, physiotherapy, wireless sensors, functional tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to assess the function of knee joints in patients after stroke compared to healthy people and evaluate the impact of rehabilitation on the function of knee joints in people after stroke.
Detailed description
Stroke patients were examined twice at the beginning of rehabilitation and after approximately 15 days of exercise. The control group (healthy participants) was assessed once. Wireless motion sensors connected to a mobile application were used to assess the kinematics of the knee joints. They were used to assess the range of motion in the knee joints (passive, active, active at maximum speed), proprioception (joint position sense tests), step-up test, step-down test, getting up and sitting on a chair, step and squat. Functional tests such as The Five Times Sit-to-Stand Test, Timed Up\&Go, The Step Test, the 5m walking test, and the 30-s Chair Stand Test were carried out. The strength of the knee extensors and flexors was also assessed using the Leg Force Feedback device. Balance was assessed on a posturography platform by performing tests such as standing with eyes open and closed on a stable surface and standing with eyes open and closed on an unstable surface. The symmetry of lower limb loads in a standing position was also assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke group | – | Other: RehabilitationAll patients from the stroke group were examined twice at the beginning and the end of this trial by a physical therapist. Patients participated in a rehabilitation program at the Neurological Rehabilitation Department between measurements. |
| Control group | – | –The control group consisted of healthy subjects. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study group comprised patients after stroke. The control group consisted of healthy volunteers.
Key inclusion criteria (22 listed)
- the time from stroke: less than a year,
- age: between 35 and 65 years old,
- ability to stand independently for at least 5 minutes without an assistive device,
- ability to walk 5 m independently,
- ability to communicate and understand the tasks required in the study,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationAlso: Physical rehabilitationPeople after a stroke participated in a standard rehabilitation process carried out at the neurological rehabilitation department. | Other | Stroke group |
Primary outcome
Assessment of the passive and active range of motion of the knee joint using wireless motion sensors connected to a mobile application.
Time frame: Baseline and after about 15 days of exercise.
Measurement of the passive and active range of motion of the knee joint in degrees in lying position using wireless motion sensors connected to a mobile application.
Proprioception
Time frame: Baseline and after about 15 days of exercise.
Assessment of joint position sensation (3 different positions indicated) in degrees using wireless sensors.
Assessment of the active range of motion of the knee and hip joint during functional tasks
Time frame: Baseline and after about 15 days of exercise.
Measurement of the range of motion of the knee and hip joint using wireless motion sensors connected to a mobile application during functional tasks such as: step up, step down, squat, sitting on a chair and getting up from a chair and step forward.
Assessment of the maximum angle of varus and valgus at the knee joint during functional tasks
Time frame: Baseline and after about 15 days of exercise.
Measurement of the maximum angle of varus and valgus at the knee joint using wireless motion sensors connected to a mobile application during functional tasks such as: step up, step down, squat, sitting on a chair and getting up from a chair and step forward.
Assessment of the mean squared error at the knee joint during functional tasks
Time frame: Baseline and after about 15 days of exercise.
Measurement of the mean squared error using wireless motion sensors connected to a mobile application during active flexion and extension motion in the knee joint at maximum speed and functional tasks such as: step up, step down, squat, sitting on a chair and getting up from a chair and step forward.
Assessment of the speed of movement in the knee joint during functional tasks
Time frame: Baseline and after about 15 days of exercise.
Measurement of the speed of movement in the knee joint during active flexion and extension motion in the knee joint at maximum speed and functional tasks such as: squat and sitting on a chair and getting up from a chair.
Step test
Time frame: Baseline and after about 15 days of exercise.
Assessment of the number of repetitions.
The Five Times Sit-to-Stand Test
Time frame: Baseline and after about 15 days of exercise.
Assessment of task completion time.
Timed Up&Go Test
Time frame: Baseline and after about 15 days of exercise.
Assessment of task completion time.
30-s Chair Stand Test
Time frame: Baseline and after about 15 days of exercise.
Assessment of the number of repetitions.
5m walking test
Time frame: Baseline and after about 15 days of exercise.
Assessment of task completion time.
Assessment of isometric muscle strength of knee flexors and extensors using Leg Force Feedback device.
Time frame: Baseline and after about 15 days of exercise.
Measurement of the maximal voluntary isometric contraction torque of the knee extensor and flexor muscle groups in Newton-meter.
Symmetry
Time frame: Baseline and after about 15 days of exercise.
Assessment of the load on the lower limbs while standing in percentage.
3 secondary outcomes
Assessment of the center of pressure path length when measuring on a balance platform
Time frame: Baseline and after about 15 days of exercise.
Assessment of the center of pressure velocity when measuring on a balance platform
Time frame: Baseline and after about 15 days of exercise.
Balance
Time frame: Baseline and after about 15 days of exercise.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No. The data is available in the form of an anonymized CSV sheet.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Wareńczak-Pawlicka, PhD principal investigator
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the passive and active range of motion of the knee joint using wireless motion sensors connected to a mobile application. (time frame: Baseline and after about 15 days of exercise.). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.